EzDent-i

GUDID 08800019700227

EzDent-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist. EzDent-i is intended for use as software to acquire, view, save 2D image files, and load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment.

EWOO SOFT Co., Ltd

General-purpose dental x-ray system application software
Primary Device ID08800019700227
NIH Device Record Key645202cd-4eeb-463e-b59c-27ad83a87139
Commercial Distribution StatusIn Commercial Distribution
Brand NameEzDent-i
Version Model Numberv3.2
Company DUNS688379797
Company NameEWOO SOFT Co., Ltd
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800019700227 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-11-16
Device Publish Date2021-11-08

On-Brand Devices [EzDent-i]

08800019700111EzDent-i is dental imaging software that is intended to provide diagnostic tools for maxillofaci
08800019700197EzDent-i is dental imaging software that is intended to provide diagnostic tools for maxillofaci
08800019700227EzDent-i is dental imaging software that is intended to provide diagnostic tools for maxillofaci
08800019700357EzDent-i is dental imaging software that is intended to provide diagnostic tools for maxillofaci
08800019700388EzDent-i is dental imaging software that is intended to provide diagnostic tools for maxillofaci
08800019700531EzDent-i is dental imaging software that is intended to provide diagnostic tools for maxillofaci

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